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Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT00574132
First received: December 10, 2007
Last updated: October 30, 2013
Last verified: October 2013

December 10, 2007
October 30, 2013
December 2007
June 2012   (final data collection date for primary outcome measure)
Cognitive and Functional [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00574132 on ClinicalTrials.gov Archive Site
  • Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Imaging and biochemical biomarkers of disease status [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Cognitive and Global [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Bapineuzumab in Patients With Mild to Moderate Alzheimer's Disease (ApoE4 Non-Carrier)
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Trial of Bapineuzumab (AAB-001, ELN115727) In Patients With Mild to Moderate Alzheimer's Disease Who Are Apolipoprotein E4 Non- Carriers.

This is a multicenter, double-blind, placebo controlled, randomized, outpatient multiple dose study in male and female patients ages 50 to less than 89 years with mild to moderate AD. Approximately 230 study sites in the US and Canada and up to 35 sites outside of North America will be involved. Patients will be randomized to receive either bapineuzumab or placebo. Each patient's participation will last approximately 1.5 years.

Bapineuzumab is a humanized monoclonal antibody, which binds to and clears beta amyloid peptide, and is designed to provide antibodies to beta amyloid directly to the patient.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Bapineuzumab 0.5 mg/kg
    infusion every 13 weeks for a total of 6 infusions
    Other Name: AAB-001
  • Drug: Placebo Control
    given by infusion every 13 weeks for a total of 6 infusions.
  • Drug: Bapineuzumab 1.0 m/kg
    infusion every 13 weeks for a total of 6 infusions
    Other Name: AAB-001
  • Experimental: Bapineuzumab 0.5 mg/kg
    infusion every 13 weeks for a total of 6 infusions
    Intervention: Drug: Bapineuzumab 0.5 mg/kg
  • Placebo Comparator: Placebo Control
    infusion every 13 weeks for a total of 6 infusions.
    Intervention: Drug: Placebo Control
  • Experimental: Bapineuzumab 1.0 m/kg
    infusion every 13 weeks for a total of 6 infusions.
    Intervention: Drug: Bapineuzumab 1.0 m/kg
Salloway S, Sperling R, Fox NC, Blennow K, Klunk W, Raskind M, Sabbagh M, Honig LS, Porsteinsson AP, Ferris S, Reichert M, Ketter N, Nejadnik B, Guenzler V, Miloslavsky M, Wang D, Lu Y, Lull J, Tudor IC, Liu E, Grundman M, Yuen E, Black R, Brashear HR; Bapineuzumab 301 and 302 Clinical Trial Investigators. Two phase 3 trials of bapineuzumab in mild-to-moderate Alzheimer's disease. N Engl J Med. 2014 Jan 23;370(4):322-33. doi: 10.1056/NEJMoa1304839.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1331
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Diagnosis of probable AD
  • Age from 50 to less than 89
  • Mini-Mental Status Exam score of 16-26 inclusive
  • Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD
  • Stable doses of medications (cholinesterase inhibitors and memantine allowed)
  • Caregiver able to attend all clinic visits with patient

Exclusion Criteria:

  • Significant neurological disease other than AD
  • Major psychiatric disorder
  • Significant systemic illness
  • History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years
  • Smoking greater than 20 cigarettes per day
  • Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications
  • Prior treatment experimental immunotherapeutics or vaccines for AD
  • Women of childbearing potential
  • Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
Both
50 Years to 88 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Austria,   Canada,   Germany
 
NCT00574132
ELN115727-301
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
Pfizer
Not Provided
JANSSEN Alzheimer Immunotherapy Research & Development, LLC
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP